Clinical trial of covered stent graft for dialysis access dysfunction completes enrolment

Solaris DE covered stent platform

Solaris Endovascular has announced that the DEScover clinical trial has successfully completed enrolment.

DEScover is a prospective, multicentre clinical study evaluating the Solaris DE sirolimus-eluting, electrospun polytetrafluoroethylene (PTFE) covered stent for the treatment of vascular disease in dialysis access circuits.

The study includes both native arteriovenous fistula (AVF) and prosthetic arteriovenous graft (AVG) patients and is designed to evaluate safety and target lesion primary patency (TLPP) outcomes compared with standard percutaneous transluminal angioplasty (PTA) in AVF and single-arm treatment in AVG.

“Completing DEScover enrolment ahead of schedule was an important scientific and clinical milestone,” said Leonardo Harduin (State University of Rio de Janeiro, Rio de Janeiro, Brazil), the trial’s principal investigator. “Based on what we’ve seen so far, Solaris DE has the potential to be the long-awaited solution to vascular access patency.”

Interim six‑month data from the DEScover trial presented at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–28 October, San Francisco, USA) by Harduin demonstrated 95% overall TLPP, including 100% patency in the AVG cohort and 91% patency in AVF patients treated with Solaris DE, with no device‑related serious adverse events reported at 30 days.

“These results, combined with rapid enrolment progress, reinforce the potential high impact and clinical value of pairing a modern self‑expanding platform with an electrospun PTFE barrier and controlled local drug delivery,” said Marco Costa, chief scientific & medical officer, Solaris Endovascular. “We look forward to sharing full results as follow‑up matures.”


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